Phase III Study of Hyperfractionated Radiation Therapy With or Without Simultaneaous Application of CIS-Platinum in Patients With Moderately Advanced to Advanced Cancers of the Head and Neck
20 Years
75 Years
Both
Head and Neck Cancer
Trial Information
Phase III Study of Hyperfractionated Radiation Therapy With or Without Simultaneaous Application of CIS-Platinum in Patients With Moderately Advanced to Advanced Cancers of the Head and Neck
OBJECTIVES: I. Assess the time to treatment failure (local and regional) in patients with
moderately advanced and advanced squamous cell carcinoma of the head and neck (no distant
metastases) when treated with hyperfractionated radiotherapy with vs. without 2 courses of
simultaneously administered cisplatin. II. Assess the time to distant metastatic relapse,
overall survival, and toxicity in patients receiving these treatments. III. Evaluate whether
the potential tumor-doubling time is an indicator for risk of treatment failure in patients
receiving these treatments.
OUTLINE: Randomized study. Arm I: Radiotherapy plus Single-Agent Chemotherapy followed, as
indicated, by Surgery. Hyperfractionated external-beam tumor irradiation using photon
energies of 4-6 MV or electrons of 6-12 MV (interstitial brachytherapy boost to lesions of
the oral cavity allowed); plus Cisplatin, CDDP, NSC-119875; followed, in patients with
persistent disease (at the discretion of the surgeon), by resection of primary tumor or
involved nodes. Arm II: Hyperfractionated radiotherapy followed by Surgery. Tumor
irradiation as in Arm I; followed by resection as in Arm I.
PROJECTED ACCRUAL: At least 400 patients will be accrued over 5 years. Interim analyses to
allow for early stopping will be carried out after entry of 50 and 100 patients.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically documented squamous cell cancer of the head and
neck in the following sites: Hypopharynx Larynx Oral cavity Oropharynx Stage III/IV
disease No distant metastases by the following: Chest x-ray (all patients) Liver
ultrasound or CT and bone scintigraphy (all hypopharyngeal cancers, those with involved
lower neck nodes, and as clinically indicated) Multiple sites of disease eligible provided
radiotherapy treatment volume remains acceptable
PATIENT CHARACTERISTICS: Age: 20 to 75 Performance status: WHO 0-2 Hematopoietic: WBC
greater than 3,000 Platelets greater than 100,000 Hepatic: Not specified Renal: Creatinine
clearance at least 60 ml/min No renal disease or impairment of renal function
Cardiovascular: No coronary heart disease No cardiac failure No history of pulmonary
embolism within 2 years Other: No clinical hearing impairment No peripheral neuropathy
with concomitant handicap No severe diabetes mellitus with serious vasculopathy or
neuropathy No second cancer except: Nonmelanomatous skin or lip cancer In situ carcinoma
of the cervix Blood/body fluid analyses to determine eligibility completed within 14 days
prior to registration
PRIOR CONCURRENT THERAPY: No prior treatment for head and neck cancer Excisional biopsy
for diagnosis allowed
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Primary Purpose: Treatment
Principal Investigator
Pia Huguenin, MD
Investigator Role:
Study Chair
Investigator Affiliation:
UniversitaetsSpital Zuerich
Authority:
Switzerland: Swissmedic
Study ID:
SAKK 10/94
NCT ID:
NCT00002654
Start Date:
April 1994
Completion Date:
July 2000
Related Keywords:
- Head and Neck Cancer
- stage III squamous cell carcinoma of the lip and oral cavity
- stage IV squamous cell carcinoma of the lip and oral cavity
- stage III squamous cell carcinoma of the oropharynx
- stage IV squamous cell carcinoma of the oropharynx
- stage III squamous cell carcinoma of the hypopharynx
- stage IV squamous cell carcinoma of the hypopharynx
- stage III squamous cell carcinoma of the larynx
- stage IV squamous cell carcinoma of the larynx
- Head and Neck Neoplasms
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